Zenpep FDA Approval History
FDA Approved: Yes (First approved August 27, 2009)
Brand name: Zenpep
Generic name: pancrelipase
Dosage form: Capsules
Previous Name: Zentase
Company: Allergan plc
Treatment for: Pancreatic Exocrine Dysfunction
Zenpep (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.
Development timeline for Zenpep
| Date | Article |
|---|---|
| Aug 28, 2009 | Approval Eurand Granted FDA Approval for Zenpep |
| Jun 19, 2008 | Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase) |
| Feb 21, 2008 | Eurand Granted Priority Review for Zentase NDA |
| Dec 20, 2007 | Eurand Completes New Drug Application for Zentase |
| Jun 12, 2007 | Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency |
Further information
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